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A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (CARTITUDE-6)

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daratumumab
Bortezomib
Lenalidomide
Dexamethasone
Cilta-cel
Cyclophosphamide
Fludarabine
Sponsored by
European Myeloma Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Cellular Therapy, CAR-T Therapy, BCMA CAR-T, Newly Diagnosed Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.

  • Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:

    1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
  • ECOG performance status of grade 0 or 1
  • Clinical laboratory values within prespecified range.

Exclusion Criteria:

  • Prior treatment with CAR-T therapy directed at any target.
  • Any prior BCMA target therapy.
  • Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  • Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
  • Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
  • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

Sites / Locations

  • Royal Adelaide Hospital
  • Princess Alexandra Hospital
  • Royal Prince Alfred Hospital
  • Royal Brisbane and Womens Hospital
  • Alfred Health
  • Austin Hospital
  • Peter MacCallum Cancer Centre
  • St. Vincent's Hospital
  • Fiona Stanley Hospital
  • Calvary Mater Newcastle Hospital
  • Westmead Hospital
  • UZA
  • UZ Gent
  • UZ Leuven
  • Tom Baker Cancer Center
  • Cross Cancer Institute
  • McMaster University
  • Hopital Maisonneuve-Rosemont
  • Mcgill University Health Centre
  • Ottawa Hospital Research Institute
  • (CHU) Centre Hospitalier Universitaire de Quebec Laval
  • Princess Margaret Cancer Centre
  • Vancouver General Hospital
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Fakutni nemocnice Ostrava
  • Fakultni nemocnice Plzen
  • Vseobecna fakultni nemocnice v Prague
  • CHRU de Lille - Hopital Claude Huriez
  • Hospices Civils De Lyon
  • CHU De Nantes - Hématologie Clinique
  • Aphp Direction
  • CHU Poitiers - Pôle régional de Cancérologie
  • Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis
  • CHU de Toulouse
  • University Hospital of Cologne
  • Dresden
  • Universitätsklinikum Hamburg - Eppendorf
  • Nationales Centrum für Tumorerkrankungen (NCT) Abt. Medizinische Onkologie
  • University Hospital of Leipzig
  • Tübingen
  • University Hospital of Würzburg
  • Attikon University General Hospital of AtticaRecruiting
  • 'G. Papanikolaou' Hospital of Thessaloniki
  • Hadassah University Hospita - Ein Kerem
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona
  • Policlinico S Orsola Malpighi
  • A.O.U. Policlinico S. Martino - Ematologia
  • ASST Grande Ospedale Metropolitano Niguarda
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • Fondazione Policlinico Universitario Agostino Gemelli
  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin
  • Juntendo University Hospital
  • Kyushu University Hospital - Hematology/Oncology
  • Hokkaido University Hospital-Department of Hematology
  • Hyogo College of Medicine
  • Kanazawa University Hospital
  • Nagoya City University Hospital - Department of Hematology & Oncology
  • Okayama University Hospital - Hematology/Oncology
  • Osaka metropolitan university hospital
  • Japanese Red Cross Medical Center - Hematology
  • Keio University Hospital - Hematology
  • Tohoku University Hospital - Hematology
  • Chonnam National University Hwasun Hospital
  • Asan Medical Center
  • Samsung Medical Center, Seoul
  • Seoul National University Hospital
  • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Severance Hospital, Yonsei University Health System
  • VU Medisch Centrum
  • University Medical Center Groningen
  • Radboud UMC
  • Erasmus MC
  • UMC Utrecht
  • Oslo University Hospital Ullevål - Oncology
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Clinic de Barcelona
  • Instituto Catalán de Oncología
  • Hospital Universitario Ramón y Cajal
  • Clinica Universidad de Navarra
  • HOSP. UNIV. 12 DE OCTUBRE, Madrid
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario 12 de Octubre
  • Ramon y Cajal, Madrid
  • CLINICA UNIV. DE NAVARRA, PamplonaRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital de Santiago de Compostela
  • Hosp. Virgen Del Rocio
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario la Fe, Valencia
  • Sahlgrenska Universitetssjukhuset
  • Landstinget i Ostergotland-Universitetssjukhuset i Linkoping
  • Skånes University Hospital Lund
  • Akademiska Sjukhuset
  • Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
  • Bern Inselspital
  • Lausanne CHUV Département d'oncologie
  • UniversitaetsSpital Zürich
  • Queen Elizabeth Medical Centre
  • University Hospital of Wales
  • Leeds Cancer Centre at St. James's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: DVRd + ASCT+DVRd (Standard Therapy)

Arm B: DVRd followed by Ciltacabtagene Autoleucel

Arm Description

Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 4 induction cycles. Followed by ASCT and 2 cycles of DVRd consolidation, and lenalidomide maintenance therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years

Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 6 induction cycles. Participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg), followed by lenalidomide post CAR-T cell therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist of 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
Progression free survival is defined as the time from the date of randomization to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Sustained MRD-negative CR
Sustained MRD-negative CR is defined as being MRD negative by bone marrow aspirate, as determined by NGS with a sensitivity of at least 10-5, and meeting the IMWG criteria for CR, and with MRD-negativity status confirmed at a minimum 12 months apart and without any examination showing MRD-positive status or PD in between.

Secondary Outcome Measures

Overall Response (OR)
OR is defined as participants who achieve a partial response (PR) or better according to the IMWG criteria.
Complete Response (CR) or better status
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria.
Overall Minimal Residual Disease (MRD) -negative CR
achieving MRD-negative CR, as determined by NGS at any time after the date of randomization before initiation of subsequent antimyeloma therapy.
Time to subsequent antimyeloma therapy
Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.
Progression Free Survival on Next-line Therapy (PFS2)
the time from the date of randomization to the date of event, defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death due to any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is measured from the date of randomization to the date of the participant's death.
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Scor
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.

Full Information

First Posted
February 16, 2022
Last Updated
October 12, 2023
Sponsor
European Myeloma Network
Collaborators
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05257083
Brief Title
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
Acronym
CARTITUDE-6
Official Title
A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
June 2033 (Anticipated)
Study Completion Date
August 2040 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Myeloma Network
Collaborators
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
Detailed Description
Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT). Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Cellular Therapy, CAR-T Therapy, BCMA CAR-T, Newly Diagnosed Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: DVRd + ASCT+DVRd (Standard Therapy)
Arm Type
Active Comparator
Arm Description
Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 4 induction cycles. Followed by ASCT and 2 cycles of DVRd consolidation, and lenalidomide maintenance therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
Arm Title
Arm B: DVRd followed by Ciltacabtagene Autoleucel
Arm Type
Experimental
Arm Description
Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 6 induction cycles. Participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg), followed by lenalidomide post CAR-T cell therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist of 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Daratumumab will be administered SC.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be administered SC.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Cilta-cel
Other Intervention Name(s)
JNJ-68284528
Intervention Description
Cilta-cel will be administered intravenously
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine will be administered intravenously.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Progression free survival is defined as the time from the date of randomization to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Time Frame
up to 10 years ( or 300 PFS events)
Title
Sustained MRD-negative CR
Description
Sustained MRD-negative CR is defined as being MRD negative by bone marrow aspirate, as determined by NGS with a sensitivity of at least 10-5, and meeting the IMWG criteria for CR, and with MRD-negativity status confirmed at a minimum 12 months apart and without any examination showing MRD-positive status or PD in between.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Overall Response (OR)
Description
OR is defined as participants who achieve a partial response (PR) or better according to the IMWG criteria.
Time Frame
up to 17 years
Title
Complete Response (CR) or better status
Description
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria.
Time Frame
up to 17 years
Title
Overall Minimal Residual Disease (MRD) -negative CR
Description
achieving MRD-negative CR, as determined by NGS at any time after the date of randomization before initiation of subsequent antimyeloma therapy.
Time Frame
up to 17 years
Title
Time to subsequent antimyeloma therapy
Description
Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.
Time Frame
up to 17 years
Title
Progression Free Survival on Next-line Therapy (PFS2)
Description
the time from the date of randomization to the date of event, defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death due to any cause, whichever occurs first.
Time Frame
up to 17 years
Title
Overall Survival (OS)
Description
Overall survival is measured from the date of randomization to the date of the participant's death.
Time Frame
up to 17 years
Title
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Description
The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Time Frame
up to 17 years
Title
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
Description
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
Time Frame
up to 17 years
Title
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Scor
Description
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
up to 17 years
Title
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Description
The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Time Frame
up to 17 years
Title
Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Description
The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
Time Frame
up to 280 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan. Measurable disease, as assessed by central laboratory, at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. ECOG performance status of grade 0 or 1 Clinical laboratory values within prespecified range. Exclusion Criteria: Prior treatment with CAR-T therapy directed at any target. Any prior BCMA target therapy. Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization. Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Lonergan
Phone
+31 107033123
Email
sarah.lonergan@emn.life
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee
Facility Name
Princess Alexandra Hospital
City
Brisbane
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abro
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho
Facility Name
Royal Brisbane and Womens Hospital
City
Herston
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Butler
Facility Name
Alfred Health
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spencer
Facility Name
Austin Hospital
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hocking
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khot
Facility Name
St. Vincent's Hospital
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quach
Facility Name
Fiona Stanley Hospital
City
Murdoch
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidiqi
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janowski
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micklethwaite
Facility Name
UZA
City
Antwerpen
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anguille
Facility Name
UZ Gent
City
Gent
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Vriendt
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delforge
Facility Name
Tom Baker Cancer Center
City
Calgary
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahlis
Facility Name
Cross Cancer Institute
City
Edmonton
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chu
Facility Name
McMaster University
City
Hamilton
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aljama
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LeBlanc
Facility Name
Mcgill University Health Centre
City
Montréal
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebag
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Visram
Facility Name
(CHU) Centre Hospitalier Universitaire de Quebec Laval
City
Québec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lemeiux
Facility Name
Princess Margaret Cancer Centre
City
Toronto
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stewart
Facility Name
Vancouver General Hospital
City
Vancouver
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song
Facility Name
Fakultni nemocnice Brno
City
Brno
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pour
Facility Name
Fakultni nemocnice Hradec Kralove
City
Králová
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radocha
Facility Name
Fakutni nemocnice Ostrava
City
Ostrava
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hajek
Facility Name
Fakultni nemocnice Plzen
City
Plzen
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungova
Facility Name
Vseobecna fakultni nemocnice v Prague
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Špička
Facility Name
CHRU de Lille - Hopital Claude Huriez
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manier
Facility Name
Hospices Civils De Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karlin
Facility Name
CHU De Nantes - Hématologie Clinique
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moreau
Facility Name
Aphp Direction
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohty
Facility Name
CHU Poitiers - Pôle régional de Cancérologie
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leleu
First Name & Middle Initial & Last Name & Degree
Leleu
Facility Name
Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis
City
Saint-Louis
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnulf
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrot
Facility Name
University Hospital of Cologne
City
Cologne
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scheid
Facility Name
Dresden
City
Dresden
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teipel
Facility Name
Universitätsklinikum Hamburg - Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weisel
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) Abt. Medizinische Onkologie
City
Heidelberg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raab
Facility Name
University Hospital of Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merz
Facility Name
Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Besemer
Facility Name
University Hospital of Würzburg
City
Würzburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Einsele
Facility Name
Attikon University General Hospital of Attica
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terpos
Facility Name
'G. Papanikolaou' Hospital of Thessaloniki
City
Thessaloníki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sakellari
Facility Name
Hadassah University Hospita - Ein Kerem
City
Jerusalem
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gatt
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magen
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cohen
Facility Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona
City
Ancona
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Offidani
First Name & Middle Initial & Last Name & Degree
Offidani
Facility Name
Policlinico S Orsola Malpighi
City
Bologna
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cavo
Facility Name
A.O.U. Policlinico S. Martino - Ematologia
City
Genova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aquino
First Name & Middle Initial & Last Name & Degree
Aquino
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cafro
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corradini
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Stefano
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin
City
Turin
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno
Facility Name
Juntendo University Hospital
City
Bunkyō-Ku
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ando
Facility Name
Kyushu University Hospital - Hematology/Oncology
City
Fukuoka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mori
Facility Name
Hokkaido University Hospital-Department of Hematology
City
Hokkaido
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teshima
Facility Name
Hyogo College of Medicine
City
Hyōgo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihara
Facility Name
Kanazawa University Hospital
City
Kanazawa
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miyamoto
Facility Name
Nagoya City University Hospital - Department of Hematology & Oncology
City
Nagoya
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iida
Facility Name
Okayama University Hospital - Hematology/Oncology
City
Okayama
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fujii
Facility Name
Osaka metropolitan university hospital
City
Osaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nakashima
Facility Name
Japanese Red Cross Medical Center - Hematology
City
Shibuya
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ishida
Facility Name
Keio University Hospital - Hematology
City
Shinjuku-Ku
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shimizu
Facility Name
Tohoku University Hospital - Hematology
City
Tōhoku
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yokoyama
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon
Facility Name
Samsung Medical Center, Seoul
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min
Facility Name
Severance Hospital, Yonsei University Health System
City
Sinchon-dong
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim
Facility Name
VU Medisch Centrum
City
Amsterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Van de Donk
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roeloffzen
Facility Name
Radboud UMC
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Kort
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Broijl
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minnema
Facility Name
Oslo University Hospital Ullevål - Oncology
City
Oslo
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weum Abrahamsen
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oriol Rocafiguera
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Larrea Rodriguez
Facility Name
Instituto Catalán de Oncología
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sureda Balari
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanchard Rodríguez
Facility Name
Clinica Universidad de Navarra
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodriguez Otero
Facility Name
HOSP. UNIV. 12 DE OCTUBRE, Madrid
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martínez-López
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Encinas Rodríguez
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martínez López
Facility Name
Ramon y Cajal, Madrid
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanchard
Facility Name
CLINICA UNIV. DE NAVARRA, Pamplona
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodríguez Otero
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mateos
First Name & Middle Initial & Last Name & Degree
Mateos
Facility Name
Hospital de Santiago de Compostela
City
Santiago De Compostela
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
González Pérez
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ortega
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reguera Ortega
Facility Name
Hospital Universitario la Fe, Valencia
City
Valencia
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
de la Rubia
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hansson
Facility Name
Landstinget i Ostergotland-Universitetssjukhuset i Linkoping
City
Linköping
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lagerlof
Facility Name
Skånes University Hospital Lund
City
Lund
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wichert
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlson
Facility Name
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
City
Basel
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heim
Facility Name
Bern Inselspital
City
Bern
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pabst
Facility Name
Lausanne CHUV Département d'oncologie
City
Lausanne
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairoli
Facility Name
UniversitaetsSpital Zürich
City
Zürich
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Müller
Facility Name
Queen Elizabeth Medical Centre
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferguson
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bygrave
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cook

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

Learn more about this trial

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

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